A Safety and Pharmacokinetics Study of CNTO 3157 in Healthy Japanese and Caucasian Participants

This will be a randomized (the treatment is assigned by chance), double-blind (neither the
participants nor study staff know the identity of the assigned treatment),
placebo-controlled study (one of the study medications is inactive) to investigate the
pharmacokinetics (ie, how the body absorbs and removes the study drug) and safety of
subcutaneous (administered under the skin) (SC) CNTO 3157 (a drug currently being
investigated for the treatment of asthma) in both Japanese and Caucasian men. Additionally,
an open-label cohort (where participants and study staff know the identity of the assigned
treatment) in Caucasian men will investigate the pharmacokinetics and safety of a single
intravenous (into a vein) (IV) infusion. The study will consist of 3 phases: a screening
phase, a treatment phase (comprising 2 days and 1 night at the study center) and a follow-up
period (comprising approximately 11 visits to the study center). During the double-blind SC
treatment period, participants will be randomly assigned to 1 of 3 treatment groups: group 1
will receive a single SC injection of 100 mg CNTO 3157 or placebo; group 2 will receive 2 SC
injections of CNTO 3157 (making a total dose of 300mg) or placebo; group 3 will receive 4 SC
injections of CNTO 3157 (making a total dose of 600 mg) or placebo. Group 4 (open-label
cohort) will receive a single IV infusion of 300 mg CNTO 3157. Participants will be enrolled
in each SC dose group sequentially from the lower to higher dose level. The study sponsor
and the study doctor will review the test results (in terms of safety and tolerability) for
each group before dosing participants in the next treatment group; this review will be
carried out in a blinded manner. An equal number of Japanese and Caucasian participants will
be assigned to the SC treatment groups forming 2 subgroups within each group (groups 1A, 1B,
2A, 2B, 3A and 3B). Within each SC treatment group, 10 participants will be randomly
assigned in a 4 to 1 ratio to receive CNTO 3157 or placebo. Only Caucasian participants will
be enrolled in the IV treatment group (group 4). For each treatment group, blood and urine
samples will be taken at various time points during the study. Each participant will take
part in the study for approximately 85 days. Participant safety will be monitored throughout
the study.

Inclusion Criteria:

- Participants must have a screening body weight in the range of 50 kg to 100 kg,
inclusive, and a screening body mass index of 18.5 kg/m2 to 30 kg/m2, inclusive

- Participants must be: of Japanese descent whose parents and maternal and paternal
grandparents are Japanese, as determined by participant's verbal report; Japanese
participants must have valid government issued identification; Japanese participants
must have resided outside of Japan for <= 5 years; or must be of non-Hispanic
Caucasian descent whose parents are Caucasian, as determined by participant's verbal
report

- Participants must have been exposed to herpes simplex-type 1 virus (HSV-1) as
documented by a positive serology test result for HSV-1 performed at screening, but
have no signs or symptoms suggestive of an active HSV-1 infection and are not
receiving prescription treatment or prophylaxis for HSV-1

Exclusion Criteria:

- Participant has or has had a clinically significant (viral, bacterial or parasitic)
infection, a prior history of recurrent serious infection (eg, sepsis, pneumonia or
pyelonephritis) or be immunosuppressed or have been hospitalized or received IV
antibiotics for an infection during the 2 months prior to screening

- Participant is infected with human immunodeficiency virus or tests positive for
hepatitis B virus infection or has antibodies to hepatitis C virus at screening

- Participant has received any live or attenuated virus or bacterial vaccinations
within 3 months prior to study agent administration or is expected to receive any
live virus or bacterial vaccinations during the study or up to 6 months after
administration of the study agent

- Participant has had major surgery, (eg, requiring general anesthesia) within 12 weeks
before screening, or will not have fully recovered from surgery, or has surgery
planned during the time the participant is expected to participate in the study OR
has had a major illness or hospitalization within 1 month prior to study agent
administration

- Participant has a history of, or currently active illness/disorder, considered to be
clinically significant by the Investigator or any other illness/disorder that the
Investigator considers should exclude the participant from the study or that could
interfere with the interpretation of the study results